# Guangzhou Red Pine Medical Instrument Co., Ltd.

- Location (FDA's records): Guangzhou, CN
- FDA decisions: 10 (2023–2026): 10 510(k) clearances
- Product codes: FGB (3), FAJ (3), HIH (2), FET (1), FDF (1)
- 510(k) review time since 2016: median 105 days, against 140 for FDA's reviews in the same codes and years (6 of 9 faster)
- Predicates its devices cite: 9 (5 its own); citations of its devices by later devices: 7 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Olympus Corporation of the Americas: 1 (https://510kreport.com/company/olympus-of-the-americas)
- Hysterovue, Inc.: 1 (https://510kreport.com/company/hysterovue)
- Zhuhai Pusen Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/zhuhai-pusen-medical-technology)
- Olympus Medical Systems Corp.: 1 (https://510kreport.com/company/olympus-medical-systems)

## Firms that cite its devices most
- MacroLux Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/macrolux-medical-technology)
- Shenzhen Sanping Image Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-sanping-image-technology)

## Its most-cited devices
- K241500: Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) (2024), cited by 2
- K232003: Endoscopic Video Image Processor, Single-Use Video Hysteroscope (2024), cited by 2
- K221158: Single-Use Video Flexible Ureterorenoscope System (2023), cited by 2
- K251951: Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F) (2025), cited by 1

## Recent decisions
- K262488: Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3) (Sep 9, 2026)
- K251951: Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F) (Dec 16, 2025)
- K252176: Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) (Aug 8, 2025)
- K243321: Endoscopic Video Image Processor (RP-IPD-V1000F) (Feb 7, 2025)
- K241987: Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) (Aug 2, 2024)
- K241500: Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) (Jul 12, 2024)
- K240663: Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S) (Jun 21, 2024)
- K232043: Endoscopic Video Image Processor  (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B) (Feb 16, 2024)

Source page: https://510kreport.com/company/guangzhou-red-pine-medical-instrument